Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy

Continuous glucose monitoring (CGM) systems offer real-time data to facilitate diabetes management. The novel Eversense CGM has been approved in Europe and the US. The unique characteristics are the fully implantable sensor and the sensor life up to 180 days.This expert review describes the results of clinical trials, and the accuracy and safety of the Eversense system. The overall MARD ranges from 8.5% to 9.4%, the 20/20% agreement rate ranges from 84% to 94%, and the percent of values in zones A and B on the Clarke Error Grid is 99.2%. No device-related serious adverse events have been described during pivotal trial studies. The most frequently reported device- or procedure-related adverse events are sensor adhesive patch location site irritation (0.66%), inability to remove the sensor upon first attempt (0.76%), and location site infection (0.96%). Mean A1c reduction is about 0.4% from pivotal trials and real-world studies.The Eversense system is novel and differentiated from transcutaneous CGM systems. The long life, the removable transmitter, and the on-body vibration alerts offer opportunities to properly manage diabetes with both MDI and insulin pump therapy.